Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000118404
Ethics application status
Approved
Date submitted
16/01/2025
Date registered
3/02/2025
Date last updated
29/05/2025
Date data sharing statement initially provided
3/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding Voice Problems in Adults Who Survived ICU Stays with a Breathing Machine: A Study from One Hospital
Scientific title
Assessment of Voice disorder among mechanically ventilated adult ICU survivors – A single-centre observational study (VOICE study)
Secondary ID [1] 313725 0
None
Universal Trial Number (UTN)
Trial acronym
VOICE (assessment of VOICE disorder among mechanically ventilated adult ICU survivors)
Linked study record
A related study protocol by the same PI was registered in CTRI (CTRI/2020/05/025053) in 2020. However, the study could not be initiated due to the COVID-19 pandemic. Therefore it was suspended as updated on CTRI records.
The current study is not a follow-up or sub-study. It is an original study.

Health condition
Health condition(s) or problem(s) studied:
Voice Disorder 336328 0
Condition category
Condition code
Respiratory 332865 332865 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
8
Target follow-up type
Weeks
Description of intervention(s) / exposure
Our study focuses on how mechanical ventilation with endotracheal intubation for over 48 hours affects the voice in adult ICU patients. Utilizing the vocal handicap index (VHI-10) and voice-related quality of life (V-RQOL), we measure the impact on voice and overall well-being. The VHI-10, a 10-question questionnaire, assesses the impact of voice problems, with scores above 11 indicating a significant impact. The V-RQOL questionnaire gauges the burden of these issues. Both these Questionnaires will be given to patients at 8 weeks after liberation from mechanical ventilation.

Each questionnaire contains 10 items and it takes approximately 3-4 minutes to complete each questionnaire and 8 minutes in total to complete these self assessment forms.
Intervention code [1] 330320 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340387 0
Quantifying voice disorder at 8 weeks after liberation from mechanical ventilation using Rosen’s vocal handicap index (VHI-10) instrument.
Timepoint [1] 340387 0
8 weeks following extubation
Secondary outcome [1] 443928 0
To measure the effect of voice disorder on quality of life using voice related quality of life (V-RQOL) instrument.
Timepoint [1] 443928 0
8 weeks following extubation.
Secondary outcome [2] 443929 0
Quantifying voice disorder at ICU discharge using Rosen’s VHI-10 instrument among patients who were mechanically ventilated (24-48 hours following extubation or at the time of ICU discharge, whichever comes sooner).
Timepoint [2] 443929 0
24-48 hours following extubation or at the time of ICU discharge, whichever comes sooner
Secondary outcome [3] 443930 0
Evaluation of risk factors associated with voice disorder.
Timepoint [3] 443930 0
Baseline

Eligibility
Key inclusion criteria
ICU patients aged 18 years or over, who have been invasively mechanically ventilated for 48 hours or more are planned to transfer from ICU to a ward environment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Those who have refused to give consent
• Extubated as a part of comfort care/end of life care/discharge against medical advice or to other hospital
• Those who are incapable of interpreting and understanding the questionnaire.
• Those who are unlikely to survive for next 3 months
• Radiotherapy treatment of head and neck region in past 6 months
• Pre-existing laryngeal pathologies
• Those who had a tracheostomy

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Timing
Prospective
Statistical methods / analysis
Summary statistics will be reported using mean and standard deviation for continuous variables and median and IQR for non-normally distributed variables. VHI-10 is an ordinal scale which rates the voice disorder from 0 to 40. Multivariate logistic regression will be used to identify association between the predictors that determine the severity of VHI-10. V-RQOL is also an ordinal scale which rates the quality of life from 10 to 50. Magnitude of V-RQOL change will be reported as median with IQR. Association between VHI and V-RQOL will be tested using Correlation statistics. All the analyses will be carried out using STATA (version:17.0).

Sample size: Following assumptions were made to calculate the sample size.
Since we do not know the incidence of actual voice disorder in the mechanically ventilated ICU survivors, therefore assuming patients who sustain Acute laryngeal injury (ALgI) to have significant voice disorder.
Assuming that 57% of the mechanically ventilated ICU survivors have the ALgI, the study would require a sample size of: 377 patients for estimating the expected proportion with 5% absolute precision and 95% confidence (52% and 62%). Factoring in dropout rate of 20% in the study we require 452 patients, rounded to 455 to test our study hypothesis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/03/2025
Actual
30/04/2025
Date of last participant enrolment
Anticipated
9/03/2027
Actual
Date of last data collection
Anticipated
4/05/2027
Actual
Sample size
Target
455
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 27494 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 43604 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 318186 0
Hospital
Name [1] 318186 0
The Canberra Hospital Private Practice Fund Administration (TCH PPFA) Funding
Country [1] 318186 0
Australia
Primary sponsor type
Individual
Name
Kiran Kumar Gudivada, Sr registrar/Fellow, Intensive Care Medicine, The Canberra Hospital
Address
Country
Australia
Secondary sponsor category [1] 320572 0
Individual
Name [1] 320572 0
Sumeet Rai, Sr Staff Intensivist, Clinical Lead – Research ICU, Intensive Care Medicine, The Canberra Hospital
Address [1] 320572 0
Country [1] 320572 0
Australia
Secondary sponsor category [2] 320579 0
Individual
Name [2] 320579 0
Harshel Parikh, Sr Staff Intensivist, Intensive Care Medicine, The Canberra Hospital
Address [2] 320579 0
Country [2] 320579 0
Australia
Secondary sponsor category [3] 320580 0
Individual
Name [3] 320580 0
Imogen Mitchell, Executive Director Research and Academic Partnerships, Canberra Health Services and the Australian National University
Address [3] 320580 0
Country [3] 320580 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316838 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 316838 0
Ethics committee country [1] 316838 0
Australia
Date submitted for ethics approval [1] 316838 0
20/06/2024
Approval date [1] 316838 0
25/09/2024
Ethics approval number [1] 316838 0
2024.LRE.00128

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139162 0
Dr Kiran Kumar Gudivada
Address 139162 0
Department of Intensive Care, Canberra Hospital, Garran 2605, Canberra ACT
Country 139162 0
Australia
Phone 139162 0
+61 02 5124 3303
Fax 139162 0
Email 139162 0
[email protected]
Contact person for public queries
Name 139163 0
Nourse, Mary
Address 139163 0
Department of Intensive Care, Canberra Hospital, Garran 2605, Canberra ACT
Country 139163 0
Australia
Phone 139163 0
+61 02 5124 3303
Fax 139163 0
Email 139163 0
[email protected]
Contact person for scientific queries
Name 139164 0
Kiran Kumar Gudivada
Address 139164 0
Department of Intensive Care, Canberra Hospital, Garran 2605, Canberra ACT
Country 139164 0
Australia
Phone 139164 0
+61 02 5124 3303
Fax 139164 0
Email 139164 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    ACT Health Ethics approval letter 8.4 - 2024.LRE.00128 - Gudivada.pdf
Informed consent form    Kiran Gudivada_VOICE_PIS.doc
Study protocol    VOICE Study protocol - V2-21 sept 2024 clean.docx


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.